- To confirm long-term safety and reliability of BIOTRONIK’s family of ICD leads, as used in conjunction with BIOTRONIK ICD pulse generators.
- To evaluate the overall incidence of serious adverse events related to the Linox family of ICD leads.
- To evaluate the incidence of each type of serious adverse event that contributes to Primary Endpoint 1.
- Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-enrollment
- Electrical characteristics of each individual Linox lead system, measured at scheduled GALAXY registry follow ups through 5 years post-enrollment
- Successfully implanted Linox lead system connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment
- Able to understand the nature of the registry and provide informed consent
- Available for follow-up visits on a regular basis at the investigational site
- Age greater than or equal to 18 years
|Main Exclusion Criteria|
- Enrolled in any IDE clinical study
- Planned cardiac surgical procedures or investigational measures within the next 6 months
- Expected to receive a heart transplant within 1 year
- Life expectancy less than 1 year
- Presence of another life-threatening, underlying illness separate from their cardiac disorder
- Linox and Linoxsmart ICD lead systems
- Leads must be used in conjunction with a BIOTRONIK ICD
- At least once every 6 months per site's institutional standard of care.
- Study start date January 2009. Estimated study completion November 2016.